Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K813598 |
Device Name |
101 TOTAL CONDYLAR KNEE SYSTEM |
Applicant |
INTERMEDICS ORTHOPEDICS |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
INTERMEDICS ORTHOPEDICS |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 12/28/1981 |
Decision Date | 02/10/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|